#Japan #Tokyo #Boston Scientific #FARAPULSE™ #FARAWAVE

Boston Scientific's Groundbreaking FARAPULSE™ System Enhancements

Boston Scientific Japan has recently announced a significant advancement to its FARAPULSE™ Pulse Field Ablation (PFA) system. On April 24, the company confirmed that it has received approval for modifications that add new 3D mapping capabilities to the system, originally launched in November of last year. The FARAPULSE™ system is designed to treat drug-resistant recurrent symptomatic paroxysmal atrial fibrillation (AF), and this modification aims to enhance the efficiency and accuracy of the treatment.

Streamlined Atrial Fibrillation Treatment

The key update involves the introduction of the FARAWAVE™ 2.0 NAV PFA catheter, which incorporates advanced magnetic navigation features. This cutting-edge catheter enables healthcare professionals to perform both PFA treatment and real-time 3D mapping using a single device. The addition of the FARAVIEW™ software module further supports this process, allowing for real-time visualization of the catheter’s location, shape, and ablation history. This dual capability is poised to revolutionize how atrial fibrillation is treated, providing immediate feedback to physicians during procedures.

Dr. Kazuhiro Satomi, the Director of the Department of Cardiology at Tokyo Medical University Hospital, emphasized the significance of this advancement, stating, "The introduction of PFA has opened up new possibilities for treating atrial fibrillation. With FARAPULSE™, we are witnessing the adoption of pioneering technologies in Japan. The visualization technology enabled by FARAVIEW is expected to enhance operational precision, ultimately improving the treatment environment for both physicians and patients."

Product Features

FARAWAVE™ 2.0 NAV PFA Catheter:

• - Single Catheter Functionality: This innovative catheter allows for both mapping and treatment simultaneously.
• - Real-time Visualization: With integrated mapping systems, the catheter’s position and movement can be monitored live, enhancing procedural accuracy.

FARAVIEW™ Software Module:

• - 3D Mapping Visualization: This software provides real-time mapping visuals, reducing exposure time and potentially minimizing unnecessary ablation sessions.
• - Automated Tagging: The software automatically records and displays ablation history, streamlining procedural efficiency.

The FARAWAVE™ 2.0 NAV PFA catheter and FARAVIEW™ software module are expected to gain approval in the U.S. by October 2024 and in Europe by February 2025. Medical professionals have already praised these enhancements, noting that real-time monitoring of the ablation process significantly increases treatment accuracy.

A Commitment to Improved Patient Care

According to Tomoyuki Morikawa, President of Boston Scientific Japan, "We are committed to advancing innovative technologies to provide safer and more efficient treatment options. The evolution of the FARAPULSE™ system has the potential to alleviate the burdens faced by medical professionals while delivering optimal care to a greater number of patients. We will continue to enhance collaboration with relevant academic societies to promote the adoption of PFA treatment."

The official sale of the FARAWAVE™ 2.0 NAV PFA catheter and FARAVIEW™ software module in Japan will begin after securing insurance reimbursement. Additionally, the company plans to showcase these groundbreaking products at the upcoming Catheter Ablation Conference from May 29 to 30, 2025, at the Okinawa Convention Center.

Addressing the Challenge of Atrial Fibrillation

Japan's healthcare system is increasingly challenged by the growing prevalence of atrial fibrillation, projected to exceed 1 million cases by 2030. The FARAPULSE™ system represents a vital innovation in the treatment landscape, utilizing a catheter to form electric fields (pulse fields) that electrically isolate the atria to block abnormal electrical signals. This technology aims to selectively ablate only the affected heart muscle, ensuring a safer procedure.

Since its European launch in 2021, the FARAPULSE™ system has garnered approval in over 65 countries and has been used in more than 200,000 clinical cases. Over 120 peer-reviewed studies have demonstrated its efficacy and safety, further solidifying its position in modern medical practice. In Japan, the system received regulatory approval on September 26, 2024, with nationwide availability starting on November 1.

In conclusion, Boston Scientific remains a leader in the treatment of cardiovascular diseases, including atrial fibrillation, myocardial infarction, and sudden cardiac death. Through the introduction of innovative and evidence-based therapies, the company continues to provide peace of mind to patients and their families throughout Japan.